Kornimate/medical-research-clean huggingface dataset:
automated pupillometry in patients underwent cardiac surgery to predict postoperative delirium

Conditions: Postoperative Delirium

Summary: the rate of postoperative delirium in patients who underwent cardiac surgery is very high. different predictors and/or scores were studied for the prediction of post operative delirium (pod)after heart surgery, but none of them was validated. the investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery. the goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (npi-200) ( ap), could predict postoperative delirium.

consent was obtained during the hospitalization before the planned surgery. on the day of surgery, before general anesthesia is started, near-infrared spectroscopy (nirs) sensors are applied to the patient's forehead bilaterally and the baseline value is recorded. pupils' variables (i.e., diameter, % constriction, constriction velocity, dilation velocity, latency, npi) are also recorded from both the right and left eye with ap (npi-200). from the induction of anesthesia, pupillary variables in both eyes are recorded and measured every 30' such as the concomitant nirs values (at least one measurement per eye per operative phase). moreover, hemodynamic and respiratory parameters concomitant with the pupillary measurements are measured. following surgery, the patient is transferred to the cardiac intensive care unit. there, nirs monitoring as as well as automated pupillometry measurements will be maintained until the patient regains consciousness (defined as rass sedation scale \>-3). once the patient has regained consciousness (rass\>-3), is assessed twice a day (morning and afternoon) with the confusion assessment method-intensive care unit (cam-icu) score by the nursing staff and/or medical staff. the presence or absence of pod will then be reported as well as any pharmacological and non-pharmacological treatments. any neurological complications and diagnostic investigations arising in the post-operative period will also be noted.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective open cardiac surgery (\>18 yr) * elective open cardiac surgery and cardiopulmonary bypass exclusion criteria: * patients \<18 years of age * emergency surgeries * heart operations, not including extracorporeal circulation * surgery for aortic arch dissection with hypothermia and/or circulatory arrest * patients affected by psychiatric disorders undergoing with or without neuroleptic therapy * patients who have the refused consent * patients with ocular problems (acute or previous trauma to one or both eyes, blindness, ocular prosthesis)

Keywords: automated pupillometry cardiac surgical procedures
eminem: efficacy of muscoril in neck myofascial syndromes

Conditions: Myofascial Pain Syndromes

Summary: study objective: * to demonstrate, in patients with myofascial pain syndrome in cervical region, the degree of efficacy of thiocolchicoside ointment administered to trigger point regions compared with the trigger point injection.


Eligibility criteria:
inclusion criteria: * submitted to clinic with a complaint of head and neck pain * be diagnosed as having myofascial pain syndrome by determining the active trigger points in trapezius and/or interscapular region according to criteria of simons and travel * have 1 to 8 active trigger point(s) exclusion criteria: * have evident cervical discopathy and signs of osteoarthritis * have bleeding diathesis or using anticoagulant medication which hinders injection * have known malignity, being used steroids, have immunodepressive disorders and/or being taken immunodepressive drugs * be pregnant or have the possibility of being pregnant or not being used a regular contraceptive method * have known allergic reaction against thiocolchicoside
asr-xl metal-on-metal 522 post-market surveillance study

Conditions: Adverse Local Tissue Reaction; Total Hip Arthroplasty

Summary: the purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the asr-xl mom system.


Eligibility criteria:
inclusion criteria: 1. able to (or capable of) provide written, voluntary consent to participate in the clinical investigation, 2. is willing and able to return for all protocol defined clinic visits, 3. subject has (or had, if previously revised) a combination of the following implants in the study hip: 1. asr-xl cup or asr 300 cup 2. xl femoral head 3. asr-xl tapered sleeve adapter 4. one of the following stems i. s-rom ii. corail iii. tri-lock iv. aml v. summit vi. prodigy vii. c-stem amt 4. subject has high quality films available for review that were taken within 12 months of primary surgery of the following views: 1. standing ap-pelvis 2. standing ap-proximal femur (if this view is not available but the ap-pelvis shows the entire implant and greater trochanter, that is also acceptable) 3. lauenstien lateral proximal femur (lateral-femur). exclusion criteria: 1. the subject refuses to allow their medical records to be inspected by the sponsor, representatives of the sponsor, the medical office staff and/or representatives from the fda 2. the implanted hip components in the study hip (exclusive of cement), are not all depuy components 3. the femoral component is the asr hemi or some other hemi device.

Keywords: adverse local tissue reaction metal ions serum whole blood metal-on-metal total hip arthroplasty asr-xl metal-on-metal revised asr-xl metal-on-metal
an open-label study of oral nnz-2591 in pitt hopkins syndrome (pths-001)

Conditions: Pitt Hopkins Syndrome

Summary: a study of the safety, tolerability and pharmacokinetics of nnz-2591 and measures of efficacy in children and adolescents with pitt hopkins syndrome.

the primary purpose of this study is to investigate the safety, tolerability and pharmacokinetics of treatment with nnz-2591 oral solution in children and adolescents with pitt hopkins syndrome. the secondary purpose is to investigate measures of efficacy. subjects will receive treatment with nnz-2591 oral solution (50 mg/ml) doses for a total of 13 weeks.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of pths with a documented disease-causing genetic etiology for the disorder. 2. males or females aged 3-17 years. 3. body weight of 12kg or higher at screening 4. subjects with a clinical global impression- severity (cgi-s) score of 4 or greater at the screening visit. 5. not actively undergoing regression or loss of skills, defined as no persistent loss of previously acquired developmental skills for a period within 3 months of the screening visit 6. each subject must be able to swallow the study medication provided as a liquid solution. 7. caregiver(s) must have sufficient english language skills. exclusion criteria: 1. body weight \<12kg at screening 2. clinically significant abnormalities in safety laboratory tests and vital signs at screening. 3. abnormal qtcf interval or prolongation at screening. 4. any other clinically significant finding on ecg at the screening visit. 5. positive for severe acute respiratory syndrome coronavirus 2 (sarscov-2) and previous covid 19 infection with last 12 months that required hospitalization. 6. unstable or changes psychotropic treatment 2 weeks prior to screening 7. excluded concomitant treatments. 8. actively undergoing regression or loss of skills. 9. unstable seizure profile. 10. current clinically significant renal conditions and abnormalities 11. current clinically significant cardiovascular, hepatic, gastrointestinal, respiratory, endocrine disease, or clinically significant organ impairment. 12. current clinically significant hypo- or hyperthyroidism, type 1 or type 2 diabetes mellitus requiring insulin (whether well controlled or uncontrolled), or uncontrolled type 1 or type 2 diabetes. 13. has planned surgery during the study. 14. history of, or current, cerebrovascular disease or brain trauma. 15. history of, or current catatonia or catatonia-like symptoms. 16. history of, or current, malignancy. 17. current major or persistent depressive disorder (including bipolar depression). 18. significant, uncorrected visual or uncorrected hearing impairment. 19. allergy to strawberry. 20. positive pregnancy test 21. subject is judged by the investigator or medical monitor to be inappropriate for the study

Keywords: pitt hopkins syndrome
esthetic evaluation of onlay restorations constructed from vita ambria glass ceramics

Conditions: Dental Caries; Tooth Decay

Summary: there is limited data available on vita ambria glass ceramic , so this study is conducted to investigate the esthetic parameters of this new glass press system.

this study will be randomized, double blinded, 1:1 parallel group, superiority clinical trial. including two research groups; vita ambria ( intervention) and ips e.max press( comprator). the total subjects in this study are 50, recruited from the faculty' out patient clinic. 50 partial coverage indirect restorations will fabricated and cemented for each subject. clinical evaluations will be conducted at baseline, 6, and 12 months of follow-up according to fdi world dental federation criteria by two independent evaluators. the primary outcome is examining the color stability and translucency.

Eligibility criteria:
inclusion criteria: participants in this trial should be healthy, between 18-50 years old, have normal occlusion, well aligned teeth, and good oral hygiene. both sexes will be included. participants should present with one or more of their posterior teeth having moderate-size coronal decay or old filling. the target teeth should be free from any signs and symptoms and should have complete root apex with no fracture as determined by the radiograph. exclusion criteria: incapable of self-care, mental illness, undergoing radiotherapy, epilepsy, diabetic patient, pregnancy, allergy to one of the materials used, smokers, parafunctional habits, poor oral hygiene, severe periodontitis, teeth need surgical crown lengthening or marginal elevation, teeth with enamel discoloration or enamel/dentin hypoplasia or hypocalcification, malaligned or malformed teeth and adjacent or opposing teeth are missed. third molars and teeth need vital pulp therapy will also be excluded.

Keywords: inlay, e.max, vita ambria, glass, cermaics, onlay, overlay
efficacy and safety of dlbs3233 in subjects with new onset of type 2 diabetes mellitus

Conditions: Type-2-diabetes Mellitus; New Onset

Summary: this is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of dlbs3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by a1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, homa-ir, homa-b, adiponectin level, lipid profile, and body weight.

there will be two groups of treatment in this study who will receive dlbs3233 or placebo of dlbs3233 (with lifestyle modification) for 12 weeks of therapy. clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. other clinical and laboratory examinations will be performed at baseline and at the end of study.

Eligibility criteria:
inclusion criteria: * male or female subjects with age of 18-60 years * bmi ≥ 18.5 kg/m2 * newly diagnosed (new onset of) type 2 dm subjects, defined as fpg level of ≥ 126 mg/dl or 2h-pg level of ≥ 200 mg/dl or a1c of ≥ 6.5%) * fpg ≤ 183 mg/dl * hemoglobin level of ≥ 10.0 g/dl * serum alt ≤ 2.5 times upper limit of normal * serum creatinine \< 1.5 times upper limit of normal exclusion criteria: * female of childbearing potential * subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment * uncontrolled hypertension (sbp \> 160 mmhg and/or dbp \> 100 mmhg) * history of renal and/or liver disease * history of or the presence of any clinical evidence of malignancies * presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections * current treatment with systemic corticosteroids or herbal (alternative) medicines * participation in any other intervention trial within 30 days prior to screening

Keywords: dlbs3233 new onset type-2-diabetes mellitus oral anti-hyperglycemic agent
the effect of gnrh on pitutitary hormones in menstrual-cycle mood related disorders

Conditions: Depressive Disorder; Healthy; Mental Disorders; Mood Disorders

Summary: the normal menstrual cycle is produced by a series of hormonal signals that starts with the release of gonadotropin-releasing hormone (gnrh) from the hypothalamus. the hypothalamus is located in the brain and is often referred to as the master gland. gnrh then acts on the pituitary gland and causes it to release two hormones, follicle stimulating hormone (fsh) and lutenizng hormone (lh). lh and fsh act on the ovary and cause it to release the hormones directly involved in menstruation, estrogen and progesterone. the purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis activity as measured by pituitary hormones, fsh and lh in response to intravenous doses of gonadotropin releasing hormone (gnrh) in menstrual cycle-related hormones.

this protocol is designed to accompany clinical protocol #81-m-0126, "the phenomenology and biophysiology of menstrually regulated mood and behavior disorders", as well as the submitted protocol, "the phenomenology and biophysiology of climacteric and menopause-related mood and behavioral disorders." its purpose will be to evaluate hypothalamic-pituitary-gonadal axis regulation as measured by pituitary gonadotropin, i.e., follicle stimulating hormone (fsh) and luteinizing hormone (lh), response to intravenous administration of gonadotropin releasing hormone (gnrh) in menstrual cycle-related mood disorders.

Eligibility criteria:
age 18-65. female. use of barrier methods of birth control. not pregnant. not taking ongoing medications. no medical illnesses.

Keywords: depression fsh gnrh lh menopause menstrual cycle
granulocyte colony stimulating factor(g-csf) therapy for patients with aclf

Conditions: Acute on Chronic Liver Failure

Summary: the purpose of the study is to determine whether granulocyte colony stimulating factor(g-csf) therapy is effective in the treatment of patients with acute on chronic liver failure(aclf). the investigators hypothesize that aclf is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. bmc mobilization using g-csf therapy, or g-csf therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with aclf.


Eligibility criteria:
inclusion criteria: * patients with acute hepatic insult manifesting as jaundice (sr. bil. ≥5 mg/dl) and coagulopathy (inr≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(apasl criteria) exclusion criteria: * hcc or portal vein thrombosis. refusal to participate in the study. sepsis ( any culture positive: blood, urine, focus of infection on xray chest, any other obvious source of infection: uti, sbp) multi organ failure. grade 3 or 4 hepatic encephalopathy.
polish revision obesity surgery study

Conditions: Metabolic Disease; Obesity, Morbid

Summary: bariatric surgery is well established method of treating patients with obesity. obesity is well-documented risk factor for many health conditions including some cancer, cardiovascular diseases, pulmonary diseases and type-2 diabetes. bariatric surgery is associated with improved comorbidities, quality of life and survival in severe obesity. however, the rate of conversion or revisional bariatric surgeries is increasing nowadays. recent date estimate the rate of revisional procedures between 8-25% of all bariatric surgeries performed worldwide. weight recidivism or fail to achieve a significant weight loss (estimated 10-20% of operated patients) remains a challenge for surgeons and patients. this has economic and health implications, leading to reduction in quality of life and increased prevalence of obesity-related comorbid conditions. therefore, the aim of this study is to identified patients with failure after primary bariatric procedure in population of poland.

all participating medical institutions performing metabolic and bariatric surgeries from poland can register patients via online questionaries. the database will include all patients with full preoperative history regarding the status of comorbidities, maximum weight and bmi. details regarding initial surgery will be collected: type of procedure, time of procedure, length of the procedure, technical aspects (type of anastomosis, location of the anastomosis, type and amount of staplers used, length of bypassed jejunum, type of gastric band), length of hospital stay, short-term complications. the outcomes of initial surgery will be noticed: %twl, minimum weight and bmi, remission of comorbidities, improvement of comorbidities, reduction of pharmacological treatment. long-term postoperative complications in example de novo reflux, stenosis of anastomosis, stricture of gastric pouch will be included in analysis. the cause of revisionary surgery will be analyzed. the secondary bariatric procedure will be analyzed in terms of time, type and its length. detail information of technical aspects will be collected. the complications and outcomes of revisional surgery will be acquired from hospitals registers, as well as, informations received from clinical follow-up.

Eligibility criteria:
inclusion criteria: patients after revisional bariatric surgery, male and females over 18 years old, any type of primary bariatric surgery. exclusion criteria: lack of follow-up, lack of anthropometric details at any point of a study.

Keywords: bariatric surgery failure revisional bariatric surgery secondary bariatric procedure
atrial fibrillation in beta-thalassemia

Conditions: Atrial Fibrillation; Thalassemia

Summary: the study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.

observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the cardiology unit of the university hospital of ferrara. patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation. the objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.

Eligibility criteria:
inclusion criteria: 1. transfusion-dependent beta-thalassemia; 2. follow-up at the cardiology unit of the university hospital of ferrara; 3. electrocardiogram performed; 4. echocardiogram performed. exclusion criteria: 1. age \<18 years; 2. state of pregnancy; 3. inability to give informed consent.

Keywords: atrial fibrillation thalassemia thalassaemia arrhythmia hemoglobinopathies
ultrasound after total shoulder arthroplasty

Conditions: Total Shoulder Arthroplasty; Rotator Cuff Tears; Rotator Cuff Injuries

Summary: the purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. we believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. in addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. our population would consist of patients that received total shoulder arthroplasty within the last 5 years.


Eligibility criteria:
inclusion criteria: * primary or revision total shoulder arthroplasty with or without subscapularis tenotomy * primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy * english speaking patients only * shoulder arthroplasty within the last 5 years exclusion criteria: * revision shoulder arthroplasty for infection * pregnancy
study of the effect of growth hormone-releasing hormone antagonist on growth hormone release in acromegaly

Conditions: Acromegaly

Summary: objectives: i. determine whether release of endogenous growth hormone (gh)-releasing hormone is involved in gh responses to clonidine, pyridostigmine, levodopa, arginine, gh-releasing peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly. ii. determine whether endogenous gh-releasing hormone influences the maintenance of gh hypersecretion.

protocol outline: growth hormone-releasing hormone antagonist (ghrh-a) is administered to volunteers and followed with 1 of these challenges: insulin, clonidine, pyridostigmine, arginine, levodopa, growth hormone-releasing peptide, or exercise. tests are repeated with normal saline as the control; the order of administration (control vs. pharmacologic stimulation) is randomly assigned. patients receive ghrh-a (dose determined in volunteer study), thyrotropin-releasing hormone, and growth-releasing hormone. all stimulation tests follow an overnight fast.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- active acromegaly with growth hormone (gh) hypersecretion confirmed within 1 month prior to entry, i.e.: somatomedin c elevated gh not below 2 ng/ml on standard 100 g oral glucose tolerance test postmenopausal and hypogonadal women eligible volunteers aged 18 to 30 recruited for up to 3 stimulation tests weight within 15% of ideal physical exam normal no history of disease no requirement for medication no medical or mental contraindication to protocol participation, including heavy alcohol or tobacco use no pregnant women --prior/concurrent therapy-- not specified --patient characteristics-- age: 18 to 65 hematopoietic: no anemia hepatic: no hepatic disease renal: no renal disease cardiovascular: no uncontrolled hypertension no heart disease other: no requirement for replacement gonadal steroids, glucocorticoids, or thyroxine no mental illness no heavy alcohol use no tobacco use no drug abuse no medical contraindication to protocol therapy

Keywords: acromegaly endocrine disorders rare disease
a study to determine if 0.6% isv-403 is safe and effective in the treatment of bacterial conjunctivitis.

Conditions: Acute Bacterial Conjunctivitis

Summary: evaluation of the clinical and microbial efficacy of 0.6% isv-403, compared to vehicle in the treatment of bacterial conjunctivitis.


Eligibility criteria:
inclusion criteria: * must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. * females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test. exclusion criteria: * pregnant or nursing females. * known hypersensitivity to fluoroquinolones or to any of the study ingredients. * use of any antibiotic within 72 hours of treatment. * any disease or condition that could interfere with the safety and efficacy evaluations of the study medications. * participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.